Published in March 2020
Updated June 2020; July 2023

The purpose of this guidance is to set forth the current intent of the Food and Drug Administration (FDA, we, or the Agency), in certain circumstances related to the impact of the coronavirus (COVID-19) outbreak. , to not apply the requirements in three food regulations to conduct on-site audits of food suppliers if other supplier verification methods are used instead.

The three regulations are Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117) (“Part 117”) (1), Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventative Controls for Animal Foods (21 CFR Part 507) (“Part 507”) (2), and the Foreign Supplier Verification Programs for importers of human and animal foods (21 CFR Part 1, Subpart L) (“FSVP Regulations”) (3).

This guidance (originally titled “Temporary Policy Regarding Preventative Controls and On-Site Verification Requirements for FSVP Food Suppliers During the COVID-19 Public Health Emergency”) was initially implemented without prior public comment on March 17, 2020, because the FDA had determined that prior public participation was necessary. is not practicable or appropriate (21 CFR 10.115(g)(2)) given the urgent circumstances related to the COVID-19 public health emergency. The FDA revised its guidance on June 4, 2020 to clarify how the policies apply to importers of dietary supplements. For the reasons discussed in section II.B., and to clarify that the policies continue to reflect our current thinking, FDA is now reissuing this guidance in accordance with 21 CFR 10.115(c) and 10.115(g)(4). The policies remain unchanged from the June 2020 guidance.

Generally, FDA guidance documents do not establish legally enforceable responsibilities. Instead, guidelines describe the Agency’s current thinking on a topic and should be considered recommendations only, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

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(1) For more information on part 117, including links to guidance that addresses the requirements mentioned in this document, see FSMA Final Rule for Preventive Controls in Human Food.

(2) For more information on part 507, including links to guidance that addresses the requirements mentioned in this document, see FSMA Final Rule for Preventative Animal Food Controls.

(3) For more information on the FSVP Regulation, including links to guidelines addressing the requirements mentioned in this document, see FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Food and Animal Food Importers.

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